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Home » FDA Clears Conformis’ Knee Replacement System
FDA Clears Conformis’ Knee Replacement System
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May 11, 2021
Conformis has received 510(k) clearance from the FDA for its Identity Imprint total knee replacement system.
The knee replacement system comes in both cruciate-retaining and posterior-stabilized versions. It uses predetermined implant sizes with standard and patient-specific surgical instrumentation, enabling faster delivery times and intraoperative options that are similar to standard knee systems.
The system uses a 3D best-fit algorithm to choose implants that are best suited for patients based on computed tomography scans. The implant is delivered using the company’s sterile surgery-in-box system that is designed to provide greater efficiency while cutting down on sterilization costs.
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